WASHINGTON, March 22 (UPI) — The U.S. Food and Drug Administration said Friday that it plans to toughen regulation of the production of defibrillators.
The move comes after years of reports of tens of thousands of defibrillator malfunctions and hundreds of deaths linked to the device, The New York Times reported.
Defibrillators are used to shock a stopped heart to allow for regular heartbeats to resume continue.
Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement that the agency was “concerned about the number of recalls and manufacturing problems that have been associated with these devices.”
The agency on Friday passed a measure that, if it is finalizes, would require companies that produce heart defibrillators to submit details of their designs and the controls they use in buying defibrillator components, many of which are purchased abroad.
A spokeswoman for Philips, one of the nine manufacturers of the device, said the FDA’s new regulation wouldn’t likely slow production of defibrillators.
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